- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418424
Narrative Writing to Promote Healthy Decisions About Alcohol During the Transition Out of College
Project SELF 2.0 Study 2 - Narrative Writing to Promote Healthy Decisions About Alcohol During the Transition Out of College
The purpose of the proposed research is to evaluate (1) whether a future possible self task (FPST) can lead to changes drinking identity (DI; how much one associates one's self with drinking) and (2) whether the FPST and changes in drinking identity also change indicators of alcohol misuse . This study focuses on individuals who are graduating from college, which is a time of transition and identity change. If such changes can be demonstrated, DI may be a mechanism for alcohol misuse and the FPST may be an additional, novel intervention strategy to reduce alcohol misuse during the post-college transition.
The goal of this clinical trial is to test the future possible self task (FPST) in individuals who are about to graduate from college.
The main questions it aims to answer are:
Can the FPST change drinking identity (a risk factor for alcohol misuse)? Can the FPST reduce risks for alcohol misuse? Participants will complete the FPST, a task that involves writing for 20 minutes, and will answer a series of questionnaires and computer-based word categorization tasks. Participants will be followed for a year after completing the FPST.
Researchers will compare different versions of the FPST and different doses (one writing sessions vs. 3 writing sessions) to see which are more effective for changing drinking identity and reducing risks for alcohol misuse.
Study Overview
Status
Conditions
Detailed Description
This study will evaluate changes in drinking identity and changes in drinking during the transition out of college in a sample of 528 soon-to-graduate or recently graduated college seniors via the future possible self task (FPST). We will test whether an adapted version of the FPST can induce change in drinking identity and reduce risk of alcohol misuse. The study will have a 2 (write about future desired self in relation to drinking vs. no), x 2 (write about future feared self in relation to drinking vs. no) x 2 (write 1x only vs.1x per week for 3 weeks) design. Participants will be randomly assigned to a condition. The study will occur entirely online, with virtual baseline and intervention sessions hosted by a research assistant and with online surveys for the 1-, 3-, 6-, and 12-month follow-ups. Participants, who receive an AUDIT score of 8 or higher, and report some interest interest in changing or not increasing their drinking, will be recruited, in equal numbers, from two sites -- one at the University of Washington and one at the University of Houston. Participants will be recruited in two waves (264 each wave, with 132 from each site during each wave).
The study will test for changes in drinking identity (primary), in indicators of alcohol misuse (primary & secondary), and in associated risk factors (secondary; changes in self-efficacy, identification with future self, and craving at baseline, 1-, 3-, 6-, and 12-month follow-ups
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77204
- University of Houston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Senior in college and expecting to graduate at the University of Washington or University of Houston
- Between the ages of 18-25
- Full time student
- Fluent in English
- Is willing to attend 3 weekly virtual laboratory sessions hosted on HIPAA-compliant Zoom
- Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)
- Scores 8 or more on the Alcohol Use Disorder Identification Test (AUDIT; cut-off for indicator of hazardous drinking) and reports drinking alcohol in the last week
- Reports at least some interest in reducing drinking
Exclusion Criteria:
- There are no exclusion criteria for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Most hoped for future self, 3 dose
Participants complete a writing task in which they think and write about their most hoped for future self, weekly for 3 weeks (i.e., at each session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most hoped for future self for 20 minutes.
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Experimental: Most hoped future self, 1 dose
Participants complete a writing task in which they think and write about their most hoped for future self one time (on the third session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most hoped for future self for 20 minutes.
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Experimental: Most feared future self, 3 dose
Participants complete a writing task in which they think and write about their most feared future self, weekly for 3 weeks (i.e., at each session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most feared future self for 20 minutes.
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Experimental: Most feared future self, 1 dose
Participants complete a writing task in which they think and write about their most feared future self one time (on the third session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most feared future self for 20 minutes.
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Experimental: Balanced self (hoped and feared self), 3 dose
Participants complete a writing task in which they think and write about their most hoped for and feared future self, weekly for 3 weeks (i.e., at each session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most hoped for and feared future self for 20 minutes.
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Experimental: Balanced self (hoped and feared self), 1 dose
Participants complete a writing task in which they think and write about their most hoped for and feared future self one time (on the third session).
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Participants in this condition complete a version of the future possible self task in which they think and write about their most hoped for and feared future self for 20 minutes.
|
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Placebo Comparator: Control, 3 dose
Participants in this condition complete a task in which they think and write about a trip to the zoo weekly for 3 weeks (i.e., at each session).
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Participants in this condition think and write about a future trip to the zoo for 20 minutes
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Placebo Comparator: Control, 1 dose
Participants in this condition complete a task in which they think and write about a trip to the zoo one time (on the third session).
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Participants in this condition think and write about a future trip to the zoo for 20 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Drinks per week
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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This is will be evaluated by the Daily Drinking Questionnaire (DDQ).
It assesses drinks consumed each day of the week during a typical week during the last month.
A sum of drinks over the course of the week will be calculated.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Peak drinks per month
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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This is will be evaluated by the Quantity/Frequency Measure (Q/F).
It includes an assessment of the number of drinks consumed when one drank the most during the last month.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Typical drinks per occasion
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
This is will be evaluated by the Quantity/Frequency Measure (Q/F).
It includes an assessment of the number of drinks consumed on a typical drinking occasion during the last month.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Alcohol-related problems
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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This is will be evaluated by the Brief Young Adult Alcohol Consequences Questionnaire. It assesses the consequences of drinking (happened yes or no) that occurred during the last month. A sum will be calculated. Higher scores indicate more experiencing more negative consequences from drinking. Scores range from 0 to 24 |
Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
|
Explicit drinking identity
Time Frame: Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
This is will be evaluated by the Alcohol Self-Concept Scale.
A mean score will be calculated.
Scores range from -3 to +3.
Higher scores indicate stronger alcohol self-concept
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Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
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Implicit drinking identity
Time Frame: Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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This is will be evaluated by the Drinking Identity Implicit Association Test (IAT).
A summary score, called a D score, which is similar to a Cohen's d effect size, will be calculated.
Scores range from -2 to +2; higher scores indicate stronger implicit drinking identity.
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Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of Alcohol Use Disorder
Time Frame: Will be assessed at baseline and at 12-month follow-up
|
This will be evaluated by the Alcohol Use Disorder Identification Test.
A total score will be calculated.
Scores range from 0 to 40.Higher scores indicate higher risk of having an alcohol use disorder
|
Will be assessed at baseline and at 12-month follow-up
|
|
Alcohol Expectancies
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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The Brief Comprehensive Effects of the Outcomes of Alcohol Questionnaire [BCEOA] will assess alcohol expectancies.
Mean scores for the BCEOA subscales will be created.
Scores range from 1 to 4. Higher scores indicate stronger expectancies about alcohol's effects.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Drinking Motives
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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The drinking motives questionnaire will assess common motives for drinking.
Mean scores for the subscales will be created.
Scores range from 1 to 5. Higher scores indicate stronger motives for drinking.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Social Norms
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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The Drinking Norms Rating Form will assess descriptive norms for drinking.
Total drinks per week that a typical same age/same gender person drinks per week will be calculated.
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Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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Alcohol Craving - Momentary
Time Frame: Will be assessed at baseline and 2 weeks after baseline
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This will be evaluated by the Alcohol Urge Questionnaire.
A mean score will be calculated.
Scores range from 1 to 7; higher scores indicate stronger momentary urges to drink .
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Will be assessed at baseline and 2 weeks after baseline
|
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Alcohol Craving - Current
Time Frame: Will be assessed 2 weeks after baseline
|
This will be evaluated by the Alcohol Craving Questionnaire-Short Form..
A sum score will be calculated.
Scores range from -3 to +3; higher scores indicate stronger urges to drink right now.
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Will be assessed 2 weeks after baseline
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Alcohol Craving - Retrospective
Time Frame: Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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This will be evaluated by the Penn Alcohol Craving Scale (PACS).
The PACS evaluate alcohol craving over the last week.
A total score will be calculated.
Scores range from 0 to 30.
Higher scores indicate stronger craving.
|
Will be assessed at baseline, 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
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Identification with Future Self
Time Frame: Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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A future self continuity measure (single item) will assess the degree to which one's current and future selves are similar.
Scores ranges from 1 to 7; higher scores indicate greater concordance between one's current and future selves.
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Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
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Readiness to Change
Time Frame: Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
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A single item readiness to change ruler will assess readiness to reduce one's drinking.
Scores range from 0 to 6; higher scores indicate greater readiness to reduce one's drinking.
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Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
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Drinking Refusal Self-efficacy
Time Frame: Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
Ability to resist drinking will be assessed by the Drinking Refusal Self-efficacy Questionnaire.
A mean score will be calculated.
Scores range from 0 to 6. Higher scores indicate greater self-efficacy to resist drinking.
|
Will be assessed at baseline, post-intervention (about 2 weeks after baseline), 1-month follow up, 3-month follow up, 6 month-follow up, & 12-month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristen Lindgren, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00024354
- R01AA030750-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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